TRANslating Sleep Health Into QUaLity of Recovery (TRANQUiL) Study: A Multi-center Prospective Cohort Study of Sleep Health and Activity Measures Predicting Meaningful and Patient-centric Outcomes Following Non-cardiac Surgeries.
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 174
- 试验地点
- 2
- 主要终点
- Quality of recovery-15 score at 48 hrs postoperatively
研究概览
简要总结
This is a novel observational study with the overarching aim of evaluating the association between poor sleep health and poor quality of recovery in a surgical setting. It hopes to assess and optimize the perioperative sleep health of patients so significant improvements in their quality of recovery and health outcomes may be achieved.
详细描述
Surgery and pain may cause sleep disturbances that affect both physical and mental well-being of patients. Sleep disturbance can cause an increased risk of confusion after surgery, increased pain needing some or more medication, untoward events (heart and breathing problems), delayed recovery and increased lengths of hospital stay.
Hospitalization interferes with sleep patterns, causing poor quality sleep due to noise, light, pain, medication administration and nursing checks. The circadian rhythm, which is the "body clock" is a 24-hour cycle that tells our bodies when to sleep and rise. This in turn helps in regulating many physiological processes in the body. Sleep disruption affects the body clock, thereby changing hormone levels that may be responsible for poor wound healing. This study aims to evaluate sleep problems before disruption post-operatively and also evaluate the relation between poor sleep health and quality of recovery utilizing sleep health measurements such as sleep quality, sleep timing, and sleep efficiency.
Objectives of the study:
- To examine the associations between specific pre-operative sleep-health parameters, predicting poor sleep health, and patient-centered outcomes such as pain control, delirium, sleep-related quality of life, and quality of recovery scores in the peri-operative period.
- To estimate the association between presence of intrinsic sleep disorders and patient centric outcomes such as pain control, delirium, sleep-related quality of life and quality of recovery scores in the post-operative period.
- To validate a set of subjective and objective measures of various sleep health domains in the post-operative period.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients (>18 years).
- •ASA physical status I - IV.
- •Undergoing elective primary or revision lower limb joint replacement surgeries (such as total or partial hip or knee replacement).
排除标准
- •Patients undergoing emergency surgeries; cardiac, trauma, organ transplantation or organ retrieval, obstetric or intracranial neurosurgeries.
- •Pregnant or lactating patients.
- •Inability to wear study-related monitoring devices per instruction or provide informed consent limiting adherence to protocol.
结局指标
主要结局
Quality of recovery-15 score at 48 hrs postoperatively
时间窗: 48 hours postoperatively
QoR-15 Score is a validated patient-reported outcome questionnaire that measures the quality of recovery after surgery and anesthesia. Aggregate changes in QoR-15 scores (e.g., mean and SD) will be reported.
The diagnostic accuracy of each of the actigraphy derived measures
时间窗: 48 hours postoperatively
The diagnostic accuracy of each of the actigraphy derived measures with reference to the standard test will be calculated using the Receiver Operating Characteristic (ROC) curve, Sensitivity, Specificity, Positive predictive value (PPV), Negative predictive value (NPV), Positive Likelihood ratio, Negative Likelihood ratios, and Diagnostic Odds Ratio (DOR).
次要结局
- Consensus Sleep Diary (CSD) Scores(7 days prior surgery, 7 days, and 3 months postoperatively)
- Functional Outcomes in Sleep Questionnaire (FOSQ)(7 days prior surgery and 3 months postoperatively)
- Hospital Anxiety and Depression Scale (HADS)(Baseline and 3 months postoperatively)
- Pittsburgh Sleep Quality Index (PSQI) Scores(3 months postoperatively)
- Fluid Intake and Output(48 hours)
- Postoperative complications(48 hours and 30 days)
- Visual analogue pain scores (VAS)(48 hours)
- Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score(Baseline and 3 months postoperatively)
- Epworth Sleepiness Scale (ESS)(Baseline and 3 months postoperatively)